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A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding (AUB)

18 Years
55 Years
Open (Enrolling)
Uterine Fibroids, Polyps

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Trial Information

A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding (AUB)

Approximately one hundred subjects will be enrolled in a randomized, comparative setting
study conducted at 10-15 investigational sites. Sixty subjects will be randomized to undergo
treatment in an office setting, and 40 subjects will be randomized to undergo treatment in a
hospital or ambulatory surgical center (ASC) setting. Subjects will undergo a hysteroscopic
tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids.
Saline infused sonohysterogram images (SIS) obtained at three months post treatment will be
compared to pre-treatment images, to determine the percent reduction in target pathology
volume. Additionally, subject self-reported pain scores (as rated on an 11 point scale) will
compare pain occurring during the treatment procedure to the average pain level experienced
during a PAP smear. Economic data will be collected and compared between the two treatment

Inclusion Criteria:

- Healthy female between 18 and 55 years of age

- Subject must be able to understand, read and sign the study specific informed consent
forms after the nature of the study has been fully explained to her

- Subject is a pre-menopausal or peri-menopausal female, either nulliparous or parous

- Subject is experiencing AUB as confirmed by a symptom raw score of 23 or a calculated
symptom score of 44.0 or higher on the Uterine Fibroid Scale and Health Related
Quality of Life (UFS-QOL)

- Subject is indicated for myomectomy or polypectomy for benign appearing pathology,
based on a hysteroscopic exam and measured by saline infused sonogram assessment
within 30 days of the planned index procedure

- Subject exhibits intrauterine polyps and/or submucous myomas which, in the opinion of
the treating physician, are compatible with office-based treatment (e.g. 15 minutes
or less of cutting time) using the MyoSure device and meet at least one of the
following criteria:

- One or more polyps, with at least one of the polyps ≥ 1.5 cm and ≤ 3.0 cm diameter
and having broad based attachment to the uterine wall.

- Up to two Type 0 or Type 1 myomas with at least one of the myomas being ≥ 1.5 cm and
none of the myomas being 3.0 cm diameter

- If the first myoma is 3.0 cm, the second myoma must be ≤ 2.0 cm

- Fundal myomas must be Type 0

- Polyps plus up to two Type 0 or Type I myomas with at least one of the myomas being ≥
1.5cm and ≤ 3.0 cm

- The subject demonstrates a negative pregnancy test within 48 hours prior to the
planned index procedure

- The subject must document a score of 5 or lower on the Pap Smear and Blood Draw
scales of the Pain Tolerance Survey

Exclusion Criteria:

- Subject has known or suspected cancer, including breast, endometrial, and ovarian

- Contraindication and/or allergy to local anesthetic, or oral medications specified in
the treatment protocol

- The subject has a history of chronic narcotic use

- Previous uterine artery embolization or other uterine artery occlusion procedure
(Doppler or laparoscopic)

- Subject has blood borne pathogens-HIV, hepatitis B, CJD, etc.

- Subject has an IUD at the time of the procedure. A subject may be enrolled in the
study if the IUD is removed prior to the treatment procedure

- Subject is taking an anticoagulant or antiplatelet medication other than low dose

- Active pelvic inflammatory disease or pelvic/vaginal infection

- Subject has a known or suspected coagulopathy or bleeding disorder

- Subject has a history of unmanaged endocrine disease

- Subject has current or past, acute or chronic psychiatric disorder which, in the
opinion of the Investigator, may preclude proper evaluation and follow-up

- Subject has a history of auto-immune, inflammatory, or connective tissue disease

- Subject has a history of disease which increases the risk for fluid overload (i.e.
significant cardiac, hepatic, or renal dysfunction)

- Uncontrolled hypertension lasting two years or more

- Use of any experimental drug or device within 30 days prior to the screening visit

- The subject has a terminal illness that may prevent the completion of any follow-up

- Any employee or relative of an employee of the Sponsor company or any Investigator
site employee or relative of employees working on the study

- Subject has other co-morbid condition(s) that, in the opinion of the Investigator,
could limit the subject's ability to participate in the study or impact the
scientific integrity of the study

- Subject has one of the following:

- Type II submucosal myoma

- Type O or Type I submucosal myoma > 3.0 cm

- Fundal Type I myoma

- Highly vascularized myoma as determined by SIS or hysteroscopic examination

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent reduction in target pathology volume

Outcome Description:

Percent reduction in target pathology volume, compared between pre-treatment baseline and month 3 post MyoSure treatment assessments, as measured by saline infused sonohysterogram.

Outcome Time Frame:

Three months post treatment

Safety Issue:


Principal Investigator

Edward Evantash, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sponsor GmbH


United States: Institutional Review Board

Study ID:

TMP 2009003



Start Date:

June 2010

Completion Date:

March 2013

Related Keywords:

  • Uterine Fibroids
  • Polyps
  • morcellator
  • hysteroscope
  • myomectomy
  • polypectomy
  • uterine fibroids
  • uterine polyps
  • office
  • cost
  • local anesthetic
  • cervical block
  • pain management
  • Leiomyoma
  • Myofibroma
  • Polyps



Complete Healthcare for Women Columbus, Ohio  43231
Phoenix Gynecology Consultants Phoenix, Arizona  85013
Boulder Women's Clinic Boulder, Colorado  80303
Women's Health Care Practice Champaign, Illinois  61820
The Research Division for Integrated Health Services Ann Arbor, Michigan  48106
Rubino OB/Gyn West Orange, New Jersey  07052
Obstetrics and Gynecology North Charleston, North Carolina  29406
Williams, Benavides, Marston, & Kaminski Raleigh, North Carolina  27609
Kulbresh Women's Center Irmo, South Carolina  29063